Abstract
Chris Anderson, Editor in Chief
Much alarm was raised recently over draft legislation announced in the U.S. Senate that seeks a potential legislative rejiggering of Section 101 of the United States Patent Act (see story page
Section 101 is the much-cited portion of U.S. patent law in the 2013 U.S. Supreme Court ruling in The Association for Molecular Pathology v. Myriad Genetics, that famously overturned Myriad's patent claims on the BRCA1 and BRACA2 genes. The issue at hand is determining what constitutes “nonobvious” use of knowledge or methods that are patentable, and those things determined to be “products and laws of nature, abstract ideas, and other general fields of knowledge.”
To me, it seems obvious that holding a patent on any human gene should not be permitted, as these are naturally occurring laws of nature. But when you begin to move beyond that, to methods for identifying genes or biomarkers and the analytic methods used to make a treatment or diagnostic determination, well, that's when things get a bit murky.
Unfortunately, as this came before a Senate subcommittee hearing in June, the battle lines were drawn in typical modern-day D.C. style: either looking for a legislative remedy for Section 101 was uncalled for, flew in the face of 150 years of precedent, and could once again lead to the patenting of human genes; or Supreme Court and lower court rulings over the past 10 years have created such uncertainty and confusion that companies are hampered in efforts to protect their IP—and hence, investment—which is stifling innovation and progress in precision medicine.
But poring over the three days of testimony on the issue of those who want to do nothing in section 101 and fall back on Court precedent, versus those who believe legislative action is necessary, it became apparent they weren't addressing the same issues. And each has a good point.
So from the ACLU's perspective—which brought the original action against Myriad—this reexamination could lead again to genes being patented, so let's not open this up again. I agree with this. Human genes should not be patentable. Researchers should not have to pay money to some entity for doing basic genetic research.
On the other hand, however, there are areas that seem to need correction. Peter O'Neill of Cleveland Clinic outlined a patent odyssey for its novel method of detecting a biomarker that can aid in predicting cardiovascular risk that saw its patent overturned twice. And David Spetzler, CSO of Caris Life Sciences, worried in his testimomy about the patentability of the company's algorithms used for determining a broad range of risk factors—a significant issue as polygenic risk scores are gaining prominence.
These areas also need addressing. The courts have seemingly made a mess of differentiating laws of nature from technologies or novel algorithms used to query these natural laws. Novel methods of detection, novel methods of analyzing genetic data, do require protection.